FDA Inspection
American Chinese Medicine Association, IncAmerican Chinese Medicine Association, Inc – FDA Inspection, Jan 20, 2022
Record Details
This FDA Inspection record concerns American Chinese Medicine Association, Inc, with an inspection on January 20, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 20, 2022
- Product Type
- Drugs
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ID · a42931e3-7ffc-42ff-b467-5f0927753a3b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1160813
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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